Clinical Evaluation of the BioFire FilmArray® BioThreat-E Test for the Diagnosis of Ebola Virus Disease in West Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioMérieux
- 入组人数
- 156
- 主要终点
- Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood.
研究概览
简要总结
The aim of our study is to assess the analytical and clinical performance of the FilmArray (FA) BioThreat-E test (BioFire®) for the diagnosis of Ebola virus disease in the field in Guinea versus conventional molecular techniques.
详细描述
The study will be conducted at the "Laboratoire des Fièvres Hémorragiques Virales" in Donka National Hospital (Conakry, Guinea), which is the Reference Laboratory for Hemorrhagic Fevers in Guinea. The reference based population includes the regions of Conakry and Coyah. No specific invasive intervention is required for this research protocol and the study does not interfere with the management of the patients according to the ongoing practices in Donka Ebola Treatment Center and in Coyah Ebola Treatment Center. Each participant will be verbally informed before signing an informed consent. Clinical data will be collected and recorded via a source document questionnaire - Clinical Report Form - based on the routine clinical data already provided to the laboratory according to the practices. Another questionnaire will be submitted to the biologist and technicians involved in the study to assess the practicability of the FilmArray technology, compared to conventional techniques, in terms of time to results, duration of test manipulation, sense of personnel safety for specimen handling, overall workload after each day, and preference of lab professionals.
As the main objective, analytical performance (sensitivity and specificity) and clinical performance (positive and negative predictive values) of the FA BioThreat-E test in whole blood will be evaluated in comparison with the QuantiTect® Probe RT-PCR (Qiagen) and the RealStar® Filovirus Type RT-PCR Kit 1.0 (Altona) both tests performed on serum.
The status for EVD will be defined for each patient based on the result of routine testing:
- Positive patients: patients enrolled in the study showing positive results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Negative patients: patients enrolled in the study showing negative results with the two routine PCR performed in the lab: QuantiTect Probe RT-PCR® and RealStar® Filovirus Type RT-PCR Kit 1.0.
- Equivocal patients: all other results showing a discrepancy between the two routine tests.
As a secondary objective, the possibility of using the FilmArray (FA) BioThreat-E test on non-invasive specimens will also be assessed. Urine and saliva specimens will be analyzed by FA for confirmed positive cases only (based on routine testing), for patients able to provide saliva and/or urine specimens according to their health condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients, male and female, older than 18, sent to Conakry or Coyah Ebola Treatment Centers for a suspicion of EVD according to WHO criteria, and considered as eligible for Ebola routine diagnosis.
- •Ability to deliver a written informed consent
排除标准
- •Age below
- •Inability to provide a consent
- •Inability to provide the blood specimens required for Ebola virus disease diagnosis.
结局指标
主要结局
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test performed on whole blood.
时间窗: Through study completion, an average of 6 months.
Number of positive/negative patients for the detection of Ebola virus RNA with the BioThreat-E test in comparision with their Ebola Virus Disease status as defined based on the result of routine testing.
次要结局
- Number of urine specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a urine specimen.(Through study completion, an average of 6 months.)
- Number of saliva specimens positive/negative for the detection of Ebola virus RNA with the BioThreat-E test, in patients positive for Ebola Virus Disease based on routine testing, and able to provide a saliva specimen.(Through study completion, an average of 6 months.)